Evaluation of the STARFlex® Septal Closure System in Patients With a Stroke or TIA Due to the Possible Passage of a Clot of Unknown Origin Through a Patent Foramen Ovale (PFO)

PHASE2/PHASE3UnknownINTERVENTIONAL
Enrollment

900

Participants

Timeline

Start Date

June 30, 2003

Study Completion Date

April 30, 2010

Conditions
Patent Foramen OvaleStrokeIschemic Attack, Transient
Interventions
DEVICE

STARFlex septal closure system

transcatheter placement of STARFlex device to close a patent foramen ovale

DRUG

Best medical therapy

aspirin (325 mg daily) and/or warfarin (target INR = 2.5)

Trial Locations (1)

44195

The Cleveland Clinic Foundation, Cleveland

Sponsors

Lead Sponsor

All Listed Sponsors
lead

NMT Medical

INDUSTRY

NCT00201461 - Evaluation of the STARFlex® Septal Closure System in Patients With a Stroke or TIA Due to the Possible Passage of a Clot of Unknown Origin Through a Patent Foramen Ovale (PFO) | Biotech Hunter | Biotech Hunter